Catalog Number

568010

Brand Name

Nox T3® Carry Case

Version/Model Number

NOX-T3_CC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082113

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

d247a90e-f605-40e6-8d34-5d800fc35db3

Public Version Date

October 26, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-